Plus Therapeutics, Inc. Q3 FY2024 earnings call

Clinical and Corporate Progress - Leptomeningeal Metastases Program: - ReSPECT-LM Phase 1 single-administration dose-escalation trial closing in on cohort 5, with FDA agreement to proceed to multiple dose escalation trial. - Presented interim data at SNO/ASCO conference, with key highlights including safety, pharmacokinetic data, and survival. - Upcoming comprehensive update at SNO Annual Meeting. - CNSide Cerebrospinal Fluid Assay Platform: - Obtained CLIA certificate of registration in Q3, intends to get CLIA certificate of compliance in Q1 2025. - Applying for Z-Code and PLA code. - Negotiating with commercial payers. - ReSPECT-GBM Trial: - Phase 1 enrollment for recurrent glioblastoma completed, Phase 2 enrollment ongoing. - Key highlights include mild to moderate adverse events, low systemic radiation exposure, and high absorbed radiation dose to tumors. - Pediatric Brain Cancer Program: - Received $0.9 million from DoD grant, anticipates IND approval in first half of 2025. - Manufacturing: - Expanding GMP manufacturing capabilities with partnership with SpectronRx for RNL production.

The company has multiple segments. The leptomeningeal metastases program with RNL (Rhenium (186Re) Obisbemeda) is in clinical trials, with progress in the ReSPECT-LM Phase 1 trial. The CNSide Cerebrospinal Fluid Assay Platform is in market access activities, with efforts to obtain CLIA certifications, Z-Code, and PLA code. The ReSPECT-GBM trial has enrollment updates, and the pediatric brain cancer program received a DoD grant. However, absolute revenue numbers for each segment and their contribution % are not explicitly detailed in the transcript.

- Presence at SNO conference in November with presentations on LM and CNSide data. - Complete ReSPECT-LM single administration trial by year-end. - Initiate enrollment in ReSPECT-LM multiple administration trial in Q1 2025. - Limited commercial release of CNSide Platform in early 2025. - Complete ReSPECT-GBM Phase 2 enrollment by mid-2025. - Obtain IND approval and initiate enrollment for pediatric brain cancer trial in 2025.

Q: How do you view the opportunities for CNSide and RNL in LM as complementary products versus on their own?

A: Marc Hedrick mentioned synergies, with CNSide providing exploratory endpoint data supporting RNL's efficacy, though not ready for primary endpoint in pivotal trial but useful as secondary.

Q: What does the landscape look for grants? Has this changed in terms of the opportunities that are available? And do you anticipate any change with the change in the incoming government?

A: Marc Hedrick stated they're in a good spot through next year, insulated by Texas, successful with CPRIT, and hope for continued opportunities there.

Q: On the LM multi-dose study, how do you guys come up with the 13 millicuries dose to be used in that study? And how does that compare to what patients have received so far through the compassionate use program?

A: Marc Hedrick discussed Bayesian approach, using cohort 4 dose (approx 44 millicuries) and fractionating for multiple dose trial, with compassionate use patients receiving higher dose but longer intervals.

Q: On the CNSide assay, what's the rough timeline for getting the inspection done as well as having reimbursements online?

A: Marc Hedrick said on track to commercialize in Q4 2024, with CLIA inspection in Q1 2025, prioritizing high-patient regions, and expecting reimbursement dominoes to fall in Q1 2025.